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Form 483

Premier Produce LLC Form 483, 2019-01-31

FDA issued a Form 483 to Premier Produce LLC on 2019-01-31 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Premier Produce LLC · Elizabethtown, United States · Issued January 31, 2019

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

31 Jan 2019
21 CFR 117.35(a)

Sanitary Operations - Plant Maintenance

Cited by Bailey A Uetrecht

31 Jan 2019
21 CFR 117.37

Sanitary Facilities and Control

Cited by Bailey A Uetrecht

Inspected site

PPPremier Produce LLCElizabethtown, United States

Inspection team

BABailey A Uetrecht

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.35(a)Cited across public-safe Form 483 observations1x
21 CFR 117.37Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere